Bioptimal Bipolar Pacing Catheter— 510(k) K242863
Substantially EquivalentBioptimal International Pte. , Ltd.
FDA 510(k) clearance K242863 for Bioptimal Bipolar Pacing Catheter, Substantially Equivalent on 2025-06-15. Applicant: Bioptimal International Pte. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Bioptimal International Pte. , Ltd.
- Product code
- Code LDF
- Device class
- Class 2
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Recent devices under product code LDF
view all- K252042 — Sync AV II Temporary Pacing Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
- K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P) +4 more
- K241199 — Rotatable Connector (5944RL)
- K242705 — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
More clearances from Bioptimal International Pte. , Ltd.
view allAdverse events under product code LDF
product code LDF- Death
- 19
- Injury
- 188
- Malfunction
- 694
- Other
- 1
- Total
- 902
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.